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TerminatedNCT04892446Updated May 2, 2025Results posted

Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 2 interventional study of Magrolimab and Daratumumab in Multiple Myeloma, sponsored by Gilead Sciences. Terminated at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated
This study was terminated early due to the Sponsor's decision to discontinue development of the investigational drug and close the program.
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab, in combination with other anticancer therapies in participants with relapsed/refractory multiple myeloma.

02

Conditions studied

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.

This study's enrollment of 36 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

All Individuals:

  • Have been previously diagnosed with MM based on the International Myeloma Working Group (IMWG) 2016 criteria and currently requires treatment.

  • Must have measurable disease as defined by 1 or more of the following:

    • Serum monoclonal protein (M-protein) ≥ 0.5 grams per deciliter (g/dL) (greater than or equal to [≥] 5 grams per liter [g/L]).
    • Urine M-protein ≥ 200 mg/24 hours (h).
    • Serum free light chain (SFLC) assay: involved SFLC level ≥ 10 mg/dL (100 mg/L) with abnormal SFLC ratio.
  • Has provided informed consent.
  • Is willing and able to comply with clinic visits and procedure outlined in the study protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy ≥ 3 months.
  • Absolute neutrophil count (ANC) ≥ 1000 cells/uL (1.0 x 10\^9/L); granulocyte colony-stimulating factor (G-CSF) is not permitted within 1 week of screening to meet eligibility criteria.
  • Platelet count ≥ 75,000 cells/uL (75 x 10\^9/L); platelet transfusion is not permitted within 1 week of screening to meet eligibility criteria.
  • Hemoglobin ≥ 9 g/dL; prior to initial dose of study treatment. Note: Transfusions are allowed to meet hemoglobin eligibility

  • Adequate liver function as demonstrated by the following:

    • Aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
    • Alanine aminotransferase (ALT) ≤ 3.0 x ULN.
    • Total bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN and primarily unconjugated if individual has a documented history of Gilbert's syndrome or genetic equivalent).
  • International normalized ratio (INR) ≤ 1.2; Individuals receiving anticoagulation treatment may be allowed to participate if INR is within the therapeutic range prior to alternate assignment.
  • Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min calculated by the Cockcroft-Gault formula or measured by 24 hours urine collection.
  • Corrected serum calcium ≤ 2.9 millimoles per liter (mmol/L) (11.5 mg/dL); measures to reduce calcium to acceptable levels, such as a short course of steroids, bisphosphonates, hydration, or calcitonin are acceptable.
  • Pretreatment blood cross-match completed.
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Must be willing to consent to mandatory pretreatment and on-treatment bone marrow biopsies (trephines).

  • Magrolimab in Combination with Daratumumab: In addition to fulfilling the inclusion criteria for all individuals, individuals who are assigned to receive magrolimab in combination with daratumumab should fulfill the following:

    • Must have received at least 3 previous lines of therapy for MM including an IMiD such as lenalidomide and a PI such as bortezomib.
    • Individuals must have not had prior anti-cluster differentiation 38 (CD38) antibody therapy for at least 6 months prior to enrollment.
    • No prior history of discontinuation of daratumumab due to toxicity.

  • Magrolimab in Combination with Pomalidomide and Dexamethasone: In addition to fulfilling the inclusion criteria for all Individuals, Individuals who are assigned to receive magrolimab in combination with pomalidomide and dexamethasone should fulfill the following:

    • Must have received at least 3 previous lines of therapy for MM including an IMiD such as lenalidomide and a PI such as bortezomib.
    • Prior treatment with pomalidomide is allowed if the Individual achieved at least a partial response (PR) to the most recent pomalidomide therapy and will have had at least a 6-month treatment-free interval from the last dose of pomalidomide until first study treatment.
    • No prior history of discontinuation of pomalidomide due to toxicity.
    • No contraindication to dexamethasone.

  • Magrolimab in Combination with Carfilzomib and Dexamethasone: In addition to fulfilling the inclusion criteria for all patients, patients who are assigned to receive magrolimab in combination with carfilzomib and dexamethasone should fulfill the following:

    • Patient must have received at least 3 previous lines of therapy for MM including an IMiD such as lenalidomide and a PI such as bortezomib.
    • Prior treatment with a PI, including carfilzomib, is allowed if the patient achieved at least a PR to the most recent prior PI therapy, and will have had at least a 6-month PI treatment-free interval from the last dose until first study treatment.
    • No prior history of discontinuation of carfilzomib due to toxicity.
    • No contraindication to dexamethasone

  • Magrolimab in Combination with Bortezomib and Dexamethasone: In addition to fulfilling the inclusion criteria for all individuals, individuals who are assigned to receive magrolimab in combination with bortezomib and dexamethasone should fulfill the following:

    • Must have received at least 1 previous line of therapy for MM including an IMiD such as lenalidomide and a PI such as bortezomib.
    • Prior treatment with a PI, including bortezomib, is allowed if the Individual achieved at least a PR to the most recent prior PI therapy, and will have had at least a 6-month PI treatment-free interval from the last dose until first study treatment.
    • No prior history of discontinuation of bortezomib due to toxicity.
    • No contraindication to dexamethasone.

Key Exclusion Criteria:

  • Individuals with known amyloidosis including myeloma complicated by amyloidosis.
  • Multiple myeloma of immunoglobulin M subtype.
  • Individuals with Waldenstrom's macroglobulinemia.
  • Individuals with myelodysplastic syndrome (MDS).
  • Plasma cell leukemia (defined as either 20% of peripheral blood white blood cell (WBC) count comprised of plasma/CD138-positive cells) or circulating plasma cells ≥ 2 x 10\^9/L.
  • Individuals with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
  • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes).
  • Glucocorticoid therapy (prednisone > 40 mg/day or equivalent) within 14 days prior to enrollment; corticosteroid therapy for hypercalcemia is allowed.
  • Chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to enrollment.
  • Focal radiation therapy within 7 days prior to enrollment; radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to less than 30% of the bone marrow).
  • Immunotherapy within 28 days prior to enrollment.
  • Major surgery (excluding procedures to stabilize the vertebrae) within 28 days prior to enrollment.
  • Positive serum pregnancy test.
  • Breastfeeding female.
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
  • Prior treatment with CD47 or signal regulatory protein alpha (SIRPα)-targeting agents.
  • Current participation in another interventional clinical trial.
  • Autologous stem cell transplant \< 100 days prior to enrollment.
  • Considered eligible to receive autologous or allogeneic stem cell transplant (SCT) at the time of enrollment.
  • Allogeneic SCT for the treatment of MM within 6 months of enrollment or active graft-versus-host disease requiring immunosuppression.
  • Significant neuropathy (Grade 3 to 4, or Grade 2 with pain) within 14 days prior to enrollment.
  • Known inherited or acquired bleeding disorders.
  • Known cirrhosis.
  • Clinical suspicion or documentation of central nervous system (CNS) disease.
  • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, congestive heart failure, or New York Heart Association (NYHA) Class III or IV heart failure.
  • Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed against reactivation) or antifungal agents within 14 days prior to enrollment.
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year. Other exceptions may be considered with sponsor approval. Previous hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV) infection in medical history.
  • Active hepatitis B virus (HBV) and/or active hepatitis C virus (HCV), and/or HIV infection following testing at screening:
  • Individuals who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
  • Individuals who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV ribonucleic acid (RNA) by quantitative PCR for confirmation of active disease.
  • Individuals who test positive for HIV.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Magrolimab+Daratumumab

    Participants with relapsed/refractory multiple myeloma (MM) who have had 3 or more prior therapies including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) will receive magrolimab as per protocol and daratumumab 1800 mg subcutaneously (SC) or 16 milligrams per kilogram (mg/kg) intravenously (IV) on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and Days 1 and 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days).

    Drug: Magrolimab · Drug: Daratumumab

  • Experimental
    Magrolimab+Pomalidomide+Dexamethasone

    Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and pomalidomide 4 mg on Days 1 to 21 (daily) of Cycle 1, Days 1 to 21 (daily) of Cycle 2 and onward and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days).

    Drug: Magrolimab · Drug: Pomalidomide · Drug: Dexamethasone

  • Experimental
    Magrolimab+Carfilzomib+Dexamethasone

    Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1, Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 is tolerated after Cycle 1, Day 8, the dose will be escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).

    Drug: Magrolimab · Drug: Dexamethasone · Drug: Carfilzomib

  • Experimental
    Magrolimab+Bortezomib+Dexamethasone

    Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the Carfilzomib + Dexamethasone cohort. Participants with relapsed/refractory multiple myeloma who have had 1 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 1.3 mg/m\^2 on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward (Maximum of 8 cycles in those who have previously received bortezomib) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, and 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).

    Drug: Magrolimab · Drug: Dexamethasone · Drug: Bortezomib

Interventions

  • DrugMagrolimab

    Administered IV

    Also known as: GS-4721

  • DrugDaratumumab

    Administered either SC or IV

  • DrugPomalidomide

    Administered orally

  • DrugDexamethasone

    Administered orally

  • DrugBortezomib

    Administered either SC or IV

  • DrugCarfilzomib

    Administered IV

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity, that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the adverse event (AE) was at least possibly related to magrolimab. Percentages are rounded off.

    Time frame: Up to 35 days

  2. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0

    An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. A treatment-emergent AE was defined as any AE that began on or after the date of first dose of any study drug up to the date of last dose of any study drug plus 70 days.

    Time frame: Up to 1.3 years plus 70 days

  3. Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0

    Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and included the date of last dose of study drug plus 70 days for participants who permanently discontinued study drug, or the day before initiation of new anticancer therapy including stem cell transplant (SCT) (whichever was earlier). If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Percentages are rounded off.

    Time frame: Up to 1.3 years plus 70 days

  4. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants who achieve confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator per the International Myeloma Working Group (IMWG) 2016 criteria. CR defined as negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow (BM) aspirates; sCR defined as CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in BM biopsy by immunohistochemistry; VGPR defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 h; PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. Percentages are rounded off.

    Time frame: Up to 1.5 years

Secondary outcomes

  1. Duration of Response (DoR)

    DoR was measured from earliest date of sCR, CR, VGPR, or PR, whichever was first recorded, until earliest date of documented progression disease (PD) per IMWG 2016, documented relapse, or death from any cause, whichever occurred first. sCR, CR, VGPR, or PR are defined in outcome measure #4. PD is having any 1 or more of following criteria: increase of 25% from lowest confirmed response value; increase between involved and uninvolved FLC levels \>10 mg/dL; increase in BM plasma-cell ≥10%; appearance of new lesion, ≥ 50% increase in sum of products of 2 longest perpendicular diameters of \>1 lesion, or ≥ 50% increase in longest diameter of a previous lesion \>1 cm in short axis; ≥ 50% increase in circulating plasma cells. Relapse is new soft tissue plasmacytomas or bone lesions; increase in size of existing plasmacytomas or bone lesions; hypercalcemia (\> 11 mg/dL); decrease in hemoglobin of ≥ 2 g/dL; rise in serum creatinine by 2 mg/dL; hyperviscosity. Kaplan Meier estimates were used.

    Time frame: Up to 1.5 years

  2. Serum Concentration of Magrolimab

    Arm 1: Magrolimab+Daratumumab; Arm 2: Magrolimab+Pomalidomide+Dexamethasone; Arm 3: Magrolimab+Carfilzomib+Dexamethasone.

    Time frame: Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13

  3. Percentage of Participants With Positive Anti-magrolimab Antibodies

    The percentage of participants who had treatment induced or treatment-boosted anti-drug antibody (ADA) based on participants who had non-missing baseline ADA sample and at least one post-treatment ADA result reported in Immunogenicity Analysis Set. Treatment-Induced ADA: participants who had negative baseline ADA sample and at least one positive post-treatment ADA sample based on participants who had both non-missing baseline and at least one post-treatment ADA result reported. Treatment-Boosted ADA: participants who had positive baseline ADA sample and at least one positive post-treatment ADA sample and the (max titer of the posttreatment ADA) / (titer of baseline ADA) \>= 4.

    Time frame: Up to Day 358

07

Results

Posted May 2, 2025
Limitations and caveats
This study was terminated early due to the Sponsor's decision to discontinue development of the investigational drug and program closure. Due to early termination of the study, reported findings should be interpreted in the context of the study's early closure.

Participant flow

43 participants were screened.

Participant flow — Overall Study
MilestoneMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Started151011
Completed758
Not completed853
Withdrew: Death440
Withdrew: Withdrew consent301
Withdrew: Investigator's discretion110
Withdrew: Study terminated by sponsor002

Outcome measures

PrimaryPercentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity, that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the adverse event (AE) was at least possibly related to magrolimab. Percentages are rounded off.

Time frame:
Up to 35 days
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
percentage of participantsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.016.716.70
PrimaryPercentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0

An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. A treatment-emergent AE was defined as any AE that began on or after the date of first dose of any study drug up to the date of last dose of any study drug plus 70 days.

Time frame:
Up to 1.3 years plus 70 days
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0
percentage of participantsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0100100100
PrimaryPercentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and included the date of last dose of study drug plus 70 days for participants who permanently discontinued study drug, or the day before initiation of new anticancer therapy including stem cell transplant (SCT) (whichever was earlier). If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Percentages are rounded off.

Time frame:
Up to 1.3 years plus 70 days
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
percentage of participantsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Hematology: Any Grade 1 or Higher92.9100100
Chemistry: Any Grade 1 or Higher92.9100100
PrimaryObjective Response Rate (ORR)

Objective response rate is defined as the percentage of participants who achieve confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator per the International Myeloma Working Group (IMWG) 2016 criteria. CR defined as negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow (BM) aspirates; sCR defined as CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in BM biopsy by immunohistochemistry; VGPR defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 h; PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. Percentages are rounded off.

Time frame:
Up to 1.5 years
Reported as:
Number · percentage of participants
Objective Response Rate (ORR)
percentage of participantsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Objective Response Rate (ORR)14.3 (1.8 to 42.8)20.0 (2.5 to 55.6)36.4 (10.9 to 69.2)
SecondaryDuration of Response (DoR)

DoR was measured from earliest date of sCR, CR, VGPR, or PR, whichever was first recorded, until earliest date of documented progression disease (PD) per IMWG 2016, documented relapse, or death from any cause, whichever occurred first. sCR, CR, VGPR, or PR are defined in outcome measure #4. PD is having any 1 or more of following criteria: increase of 25% from lowest confirmed response value; increase between involved and uninvolved FLC levels \>10 mg/dL; increase in BM plasma-cell ≥10%; appearance of new lesion, ≥ 50% increase in sum of products of 2 longest perpendicular diameters of \>1 lesion, or ≥ 50% increase in longest diameter of a previous lesion \>1 cm in short axis; ≥ 50% increase in circulating plasma cells. Relapse is new soft tissue plasmacytomas or bone lesions; increase in size of existing plasmacytomas or bone lesions; hypercalcemia (\> 11 mg/dL); decrease in hemoglobin of ≥ 2 g/dL; rise in serum creatinine by 2 mg/dL; hyperviscosity. Kaplan Meier estimates were used.

Time frame:
Up to 1.5 years
Reported as:
Median · months
Duration of Response (DoR)
monthsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Duration of Response (DoR)NA (NA to NA)NA (3.9 to NA)NA (NA to NA)
SecondarySerum Concentration of Magrolimab

Arm 1: Magrolimab+Daratumumab; Arm 2: Magrolimab+Pomalidomide+Dexamethasone; Arm 3: Magrolimab+Carfilzomib+Dexamethasone.

Time frame:
Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13
Reported as:
Mean · ng/mL
Serum Concentration of Magrolimab
ng/mLMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Predose: Cycle 1 Day 1NA ± NANA ± NANA ± NA
Predose: Cycle 1 Day 22435000 ± 245000303000 ± 182000421000 ± 115000
Predose: Cycle 2 Day 1621000 ± 233000713000 ± 293000675000 ± 274000
Predose: Cycle 3 Day 1853000 ± 399000739000 ± 365000847000 ± 238000
Predose: Cycle 4 Day 1694000 ± 827005540 ± NA459000 ± 161000
Predose: Cycle 5 Day 1517000 ± 186000373000 ± 142000448000 ± 90700
Predose: Cycle 7 Day 1332000 ± NA307000 ± 153000376000 ± 140000
Predose: Cycle 10 Day 1336000 ± NA—361000 ± 345000
Predose: Cycle 13 Day 1295000 ± NA—624000 ± NA
Anytime: Last sample collection day: Up to Day 358445000 ± 337000179000 ± 13100086000 ± 34000
SecondaryPercentage of Participants With Positive Anti-magrolimab Antibodies

The percentage of participants who had treatment induced or treatment-boosted anti-drug antibody (ADA) based on participants who had non-missing baseline ADA sample and at least one post-treatment ADA result reported in Immunogenicity Analysis Set. Treatment-Induced ADA: participants who had negative baseline ADA sample and at least one positive post-treatment ADA sample based on participants who had both non-missing baseline and at least one post-treatment ADA result reported. Treatment-Boosted ADA: participants who had positive baseline ADA sample and at least one positive post-treatment ADA sample and the (max titer of the posttreatment ADA) / (titer of baseline ADA) \>= 4.

Time frame:
Up to Day 358
Reported as:
Number · percentage of participants
Percentage of Participants With Positive Anti-magrolimab Antibodies
percentage of participantsMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Percentage of Participants With Positive Anti-magrolimab Antibodies000

Adverse events

Collected over All-cause mortality: Up to 1.5 years; Adverse events: Up to 1.3 years plus 70 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Magrolimab+Daratumumab4/15 (26.7%)5/14 (35.7%)14/14 (100%)
Magrolimab+Pomalidomide+Dexamethasone4/10 (40%)5/10 (50%)10/10 (100%)
Magrolimab+Carfilzomib+Dexamethasone0/11 (0%)4/11 (36.4%)11/11 (100%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
PneumoniaInfections and infestations0/141/102/11
Febrile neutropeniaBlood and lymphatic system disorders1/141/100/11
Acute sinusitisInfections and infestations0/141/100/11
Covid-19 pneumoniaInfections and infestations0/141/100/11
Febrile infectionInfections and infestations0/141/100/11
Klebsiella urinary tract infectionInfections and infestations0/141/100/11
Hip fractureInjury, poisoning and procedural complications0/141/100/11
Infusion related reactionInjury, poisoning and procedural complications0/141/100/11
Pathological fractureMusculoskeletal and connective tissue disorders0/141/100/11
Deep vein thrombosisVascular disorders0/141/100/11
Most frequent other events
Showing 10 of 131
Most frequent other events
EventMagrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+Dexamethasone
Platelet count decreasedInvestigations2/143/107/11
AnaemiaBlood and lymphatic system disorders7/146/106/11
FatigueGeneral disorders6/143/106/11
Neutrophil count decreasedInvestigations2/144/102/11
DiarrhoeaGastrointestinal disorders4/143/104/11
CoughRespiratory, thoracic and mediastinal disorders1/142/104/11
DyspnoeaRespiratory, thoracic and mediastinal disorders3/143/104/11
NauseaGastrointestinal disorders5/143/103/11
HeadacheNervous system disorders5/142/103/11
Respiratory tract infectionInfections and infestations1/143/100/11

Baseline characteristics

The Safety Analysis Set included all participants who received at least 1 dose of study treatment with treatment group designated according to the actual treatment received. As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms.

Age, Categorical
Age, Categorical(Participants)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
<=18 years0000
Between 18 and 65 years74516
>=65 years76619
Age, Continuous
Age, Continuous(years)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
Mean65 ± 9.566 ± 10.268 ± 8.066 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
Female102517
Male48618
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
Hispanic or Latino0000
Not Hispanic or Latino14101135
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander1001
Black or African American1113
White1191030
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)Magrolimab+DaratumumabMagrolimab+Pomalidomide+DexamethasoneMagrolimab+Carfilzomib+DexamethasoneTotal
Canada2147
United States105419
Czechia2439
08

Study locations

22 sites
  • Arizona Oncology Associates , PC - HOPE
    Tucson, Arizona 85711, United States
  • US San Diego Moores Cancer Center
    La Jolla, California 92093, United States
  • Stanford Cancer Institute
    Palo Alto, California 94305, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Memorial Sloan Kettering Cancer Center - Main Campus
    New York, New York 10065, United States
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Cleveland Clinic - Taussig Cancer Institute
    Cleveland, Ohio 44195, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Hightower Clinical
    Oklahoma City, Oklahoma 73102, United States
  • Bend Memorial Clinic, P.C. d/b/a Summit Health
    Bend, Oregon 97701, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • US Oncology, Inc. IRB
    Dallas, Texas 75246, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
  • US Oncology, Inc., IRB
    Fairfax, Virginia 22031, United States
  • Cross Cancer Institute
    Edmonton, T6G 1Z2, Canada
  • Princess Margaret Cancer Centre
    Toronto, M5G 2M9, Canada
  • Fakultní nemocnice Brno
    Brno, 625 00, Czechia
  • Fakultní Nemocnice Olomouc
    Olomouc, 779 00, Czechia
  • Vseobecna fakultni nemocnice v Praze
    Prague, 100 34, Czechia
  • Fakultní nemocnice Ostrava
    Severomoravsky KRAJ, 708 52, Czechia
09

References and documents

Publications

  • Paul B, Liedtke M, Khouri J, Rifkin R, Gandhi MD, Kin A, Levy MY, Silbermann R, Cottini F, Sborov DW, Sandhu I, Villarreal L, Murphy M, Gu L, Chen A, Rajakumaraswamy N, Usmani SZ. A phase II multi-arm study of magrolimab combinations in patients with relapsed/refractory multiple myeloma. Future Oncol. 2023 Jan;19(1):7-17. doi: 10.2217/fon-2022-0975. Epub 2023 Feb 13. PubMed 36779512 ↗
  • Paul B, Minarik J, Cottini F, Gasparetto C, Khouri J, Gandhi M, et al. Safety and Tolerability of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma: Safety Run-in Results From a Phase 2 Study [Poster 3383]. 65th American Society of Hematology (ASH) Annual Meeting; 2023 December 9-12; San Diego, California.

Study documents

  • Study protocol · Nov 2, 2023
  • Statistical analysis plan · May 13, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04892446
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
May 19, 2021
Start date
Nov 9, 2021
Primary completion
Apr 25, 2024
Completion
Apr 25, 2024
Results posted
May 2, 2025
Last update
May 2, 2025

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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